This clinical trial has been designated to study the probable effects of pomegranate extract on inflammatory biomarkers of hemodialysis patients such as CRP, IL-6 and also on two clinical outcomes, nutritional status and anemia. Inclusion criterion comprises receiving hemodialysis therapy for three consecutive months. Exclusion criteria are history of hypersensitivity to pomegranate; kidney transplant less than 6 months before study enrollment; vitamin E (60 IU/day or more), vitamin C (500 mg/day or more), or other antioxidant supplements during the month before the study; history of hospitalization during 3 months before the study; patients with life-threatening comorbidities including malignancies and being severely deconditioned. In this study 80 hemodialysis patients aging above 18 will be randomly allocated to receive pomegranate extract or placebo for 8 weeks. Changes in primary outcome variables including CRP, leptin, Interleukin-6, hemoglobin (in patients’ blood samples) and nutritional status (through MIS) will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502225161N2
Registration date:2016-06-23, 1395/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-23, 1395/04/03
Registrant information
Name
Vahideh Yavari
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 1646 7125
Email address
yavariv@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery for Research and Technology Affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Pomegranate extract on nutritional status, anemia and inflammatory biomarkers of hemodialysis patients
Public title
Pomegranate extract and hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ESRD patients on chronic hemodialysis for at least three consecutive months
Exclusion criteria: history of hypersensitivity to pomegranate; kidney transplant less than 6 months before study enrollment; vitamin E (60 IU/day or more), vitamin C (500 mg/day or more), or other antioxidant supplements during the month before the study; history of hospitalization during 3 months before the study; patients with life-threatening comorbidities including malignancies; being severely deconditioned
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee
Street address
Medical Research Ethics Committee, Vice-Chancellery for Research and Technology Affairs, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
ir.sums.rec.1394.31
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
CRP
Timepoint
before and after the intervention
Method of measurement
blood sample
2
Description
Hemoglobin
Timepoint
before and after the intervention
Method of measurement
blood sample
3
Description
Leptin
Timepoint
before and after the intervention
Method of measurement
blood sample
4
Description
Nutritional status
Timepoint
before and after the intervention
Method of measurement
MIS
5
Description
IL-6
Timepoint
before and after the intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
Adverse drug reactions
Timepoint
during intervention
Method of measurement
patient-based reports
Intervention groups
1
Description
Intervention group: 2 g of Pomegranate extract before every dialysis session for 8 weeks
Category
Treatment - Drugs
2
Description
control group: 4 capsules of placebo before every hemodialysis session
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Unit, Namazi Hospital
Full name of responsible person
Dr. Mansooreh Faghihi
Street address
Namazi Hospital, Namazi Square
City
Shiraz
2
Recruitment center
Name of recruitment center
Hemodialysis Unit, Shahid Faghihi Hospital
Full name of responsible person
Dr. Ramin Radmehr
Street address
Shahid Faghihi Hospital, Zand BLVD
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology Affairs
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, 7th floor, Zand BLVD
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research and Technology Affairs
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Nephrology Department
Full name of responsible person
Dr Jamshid Roozbeh
Position
Nephrologist/ Full professor
Other areas of specialty/work
Street address
Namazi hospital, Nephrology Department Office
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
roozbehj@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Nephrology Department
Full name of responsible person
Dr Vahideh Yavari
Position
Nephrology Fellow
Other areas of specialty/work
Street address
Namazi hospital, Nephrology Department Office
City
Shiraz
Postal code
Phone
+98 71 3647 4316
Fax
Email
yavariv@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Nephrology Department
Full name of responsible person
Dr. Vahideh Yavari
Position
Nephrology Fellow
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
yavariv@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)